Application 022386
- Type
- NDA
- Sponsor
- NOVO NORDISK INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRANDIMET | METFORMIN HYDROCHLORIDE; REPAGLINIDE | TABLET;ORAL | 500MG;1MG | Yes | No |
| 002 | PRANDIMET | METFORMIN HYDROCHLORIDE; REPAGLINIDE | TABLET;ORAL | 500MG;2MG | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 50653 | SUPPL | 2017-12-11 |
| 47949 | SUPPL | 2017-04-12 |
| 47923 | SUPPL | 2017-04-11 |
| 7311 | SUPPL | 2012-04-27 |
| 38643 | SUPPL | 2012-04-26 |
| 17304 | SUPPL | 2012-03-06 |
| 7310 | SUPPL | 2012-03-05 |
| 29668 | SUPPL | 2010-06-04 |
| 38642 | SUPPL | 2010-06-03 |
| 44744 | ORIG | 2009-04-14 |
| 42504 | ORIG | 2009-04-14 |
| 29667 | ORIG | 2008-06-26 |
| 17303 | ORIG | 2008-06-26 |